TREAT EARLY TODAY FOR HER TOMORROW1–4

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Dig into the data from C-VIEW

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C-VIEW was the first interventional clinical trial to assess the impact of CIMZIA® on acute anterior uveitis in active axSpA as a primary outcome5

CIMZIA® is not registered for the treatment of uveitis.1 
Please refer to the CIMZIA® SmPC for a complete list of licensed indications.1

CIMZIA® safety profile

The use of adequate contraception should be considered for women of childbearing potential. For women planning pregnancy, continued contraception may be considered for 5 months after the last CIMZIA® dose due to its elimination rate, but the need for treatment of the woman should also be taken into account. Data from more than 1,300 prospectively collected pregnancies exposed to CIMZIA® with known pregnancy outcomes, including more than 1,000 pregnancies exposed during the first trimester, does not indicate a malformative effect of CIMZIA®. Further data are being collected as the available clinical experience is still limited to conclude that there is no increased risk associated with CIMZIA® administration during pregnancy. CIMZIA® should only be used during pregnancy if clinically needed. CIMZIA® can be used during breastfeeding.1

Related information

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CIMZIA® is not registered for the treatment of uveitis.1 
Please refer to the CIMZIA® SmPC for a complete list of licensed indications.1

Title of this section

Title of this content. CIMZIA® demonstrated sustained remission

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Abbreviated Prescribing Information

Abbreviations 

axSpA: Axial spondyloarthritis; KOL: Key opinion leader; PsA: Plaque psoriasis; PSO: Psoriasis; Q2W: Every two weeks; RA: Rheumatoid arthritis.

Study design

C-VIEW was a 104-week (96 weeks plus 8-week safety follow-up) multicentre, open-label, phase 4 study. Eligible patients were adults who had active axSpA, HLA-B27 positivity and a history of recurrent acute anterior uveitis (≥2 acute anterior uveitis flares in total; ≥1 in the year prior to baseline). Patients received a loading dose of CIMZIA® 400 mg at weeks 0, 2, and 4, followed by a maintenance dose of CIMZIA® 200 mg every 2 weeks up to week 96. The primary efficacy endpoint was the acute anterior uveitis flare event rate during 96 weeks’ CIMZIA® vs. 2 years pre-baseline. Of 115 enrolled patients, 89 initiated CIMZIA® and 83 patients completed the week 96 visit.5

References

1. CIMZIA® Summary of Product Characteristics, July 2022. Last accessed 22/12/2022. Access the CIMZIA® SmPC

2. Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233.

3. Clowse ME, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896.

4. Rusman T, van Vollenhoven RF, van der Horst-Bruinsma IE. Gender differences in axial spondyloarthritis: women are not so lucky. Curr Rheumatol Rep. 2018 May 12;20(6):35.

5. van der Horst-Bruinsma IE, van Bentum RE, Verbraak FD et al. Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study. Ther Adv Musculoskelet Dis. 2021 Mar 29;13:1759720X211003803.

CIMZIA® Indication

CIMZIA®, in combination with methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis in adults:

  • For the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate
  • For the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. 

CIMZIA® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA® is indicated for the treatment of adult patients with severe active axial spondyloarthritis comprising:​

  • Adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs)​
  • Adults with severe active axial spondyloarthritis without radiographic evidence of AS (nr-axSpA) but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs ​
    CIMZIA®, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate​.

CIMZIA® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

EU-P-CZ-PsA-2200001

Date of preparation: February 2023

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